Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers
28 Febbraio 2024 - 2:00PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
biopharmaceutical company with marketed products and a pipeline of
development candidates, today announced the completion of the
clinical stage of its Phase 1, single ascending dose escalation
trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal
antibody, or mAb)* in healthy volunteers. TNX-1500 is in
development for the prevention of rejection in solid organ and bone
marrow transplant and for the treatment of autoimmune disorders.
“Despite advancements in the field of solid
organ transplantation, there remains a significant need for new
treatments with improved activity and tolerability,” said Seth
Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
“Anti-CD40L modulates T cell function and has the potential to
promote tolerance of transplanted organs. We are excited to have
completed the clinical stage of this Phase 1 trial of TNX-1500, a
third-generation Fc-modified anti-CD40L mAb that has been designed
by protein engineering to eliminate the risk of thrombosis
associated with first-generation anti-CD40L mAbs. Preclinical
studies in non-human primates did not result in any thrombotic
complications, suggesting that the protein engineering of
TNX-1500’s Fc region has achieved its design goals.”
Dr. Lederman continued, “Recently, positive
clinical data with other CD40L blockers have been reported by
Sanofi, with its Fc-modified humanized anti-CD40L mAb frexalimab in
treating relapsing multiple sclerosis.2 Eledon Pharmaceuticals is
developing tegoprubart, a non-covalent dimer antibody with no
heavy-light or heavy-heavy interchain disulfide bridges for the
prevention of rejection of kidney transplants3.”
Dr. Lederman concluded, “We believe TNX-1500 has
the potential to prevent organ transplant rejection and improve
graft survival with reduced long-term toxicity burden of current
immunosuppressive regimens. In addition, TNX-1500 has the potential
to address multiple other indications, including several autoimmune
diseases. We look forward to the results of this Phase 1 trial,
which are expected in the third quarter of this year, and to
continuing the development of TNX-1500 as a promising candidate in
an important therapeutic space.”
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb)
is a humanized monoclonal antibody that interacts with the
CD40-ligand (CD40L), also known as CD154. TNX-1500 is being
developed for the prevention of allograft and xenograft rejection,
for the prevention of graft-versus-host disease (GvHD) after
hematopoietic stem cell transplantation (HCT) and for the treatment
of autoimmune diseases. The first-in-human Phase 1 trial of
TNX-1500 was initiated in the third quarter of 2023. The primary
objective of the Phase 1 trial is to assess the safety,
tolerability, pharmacokinetics, and pharmacodynamics of intravenous
(i.v.) TNX-1500. Eligible participants enrolled in the Phase 1
trial were distributed across three dosing cohorts (3 mg/kg, 10
mg/kg, and 30 mg/kg, respectively) and evaluated regularly over a
120-day period after dosing. This first-in-human trial is intended
to support dosing in a planned Phase 2 trial in kidney transplant
recipients. Two published articles in the American Journal of
Transplantation demonstrate TNX-1500 prevents rejection, prolongs
survival and preserves graft function as a single agent or in
combination with other drugs in non-human primate renal and heart
allografts.4,5
About anti-CD40L Therapeutics in
Development
No anti-CD40L mAb has been approved in any
jurisdiction. In addition to TNX-1500, frexalimab and tegoprubart,
tn03 fusion protein dazodalibep is being developed by Amgen
(formerly Horizon Therapeutics Public Limited Company) for the
treatment of Sjögren's Syndrome .6,7 Dapirolizumab pegol, an
anti-CD40L pegylated Fab, is being developed by UCB for the
treatment of systemic lupus erythematosus.8
*TNX-1500 is an investigational new biologic and
is not approved for any indication
- Vermersch P., et al. N Engl J Med.
2024. 390(7):589-600 https://doi.org/10.1056/nejmoa2309439
- Sanofi press release. May 31, 2023.
https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-31-05-00-00-2678991
(accessed August 2023)
- Eledon press release. November 2,
2023.
https://ir.eledon.com/news-releases/news-release-details/eledon-reports-updated-data-ongoing-phase-1b-trial-evaluating
(accessed February 2024)
- Lassiter G., et al. Am J
Transplantation.
2023. https://doi.org/10.1016/j.ajt.2023.03.022
- Miura S., et al. Am J
Transplantation.
2023. https://doi.org/10.1016/j.ajt.2023.03.025
- BioSpace. September 12, 2022.
https://www.biospace.com/article/releases/horizon-therapeutics-plc-announces-phase-2-trial-evaluating-dazodalibep-for-the-treatment-of-sjoegren-s-syndrome-meets-primary-endpoint
(accessed February 2024)
- BioSpace. January 18, 2023.
https://www.biospace.com/article/horizon-bags-second-phase-ii-win-in-sjoegren-s-syndrome
(accessed February 2024)
-
https://www.ucb.com/our-science/pipeline (accessed August
2023)
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
developing, licensing and commercializing therapeutics to treat and
prevent human disease and alleviate suffering. Tonix’s development
portfolio is focused on central nervous system (CNS) disorders.
Tonix’s priority is to submit a New Drug Application (NDA) to the
FDA in the second half of 2024 for Tonmya1, a product candidate for
which two positive Phase 3 studies have been completed for the
management of fibromyalgia. TNX-102 SL is also being developed to
treat acute stress reaction as well as fibromyalgia-type Long
COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a
biologic designed to treat cocaine intoxication with Breakthrough
Therapy designation. Tonix’s immunology development portfolio
consists of biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the
treatment of autoimmune diseases. Tonix also has product candidates
in development in the areas of rare disease and infectious disease.
Tonix Medicines, our commercial subsidiary, markets Zembrace®
SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan
nasal spray) 10 mg for the treatment of acute migraine with or
without aura in adults.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration (FDA) as the tradename for TNX-102 SL
for the management of fibromyalgia. Tonmya has not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. All other marks are property of
their respective owners.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements are based on Tonix's
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to
differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, risks
related to the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; risks related to the failure to
successfully market any of our products; risks related to the
timing and progress of clinical development of our product
candidates; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payor reimbursement; limited research and development
efforts and dependence upon third parties; and substantial
competition. As with any pharmaceutical under development, there
are significant risks in the development, regulatory approval and
commercialization of new products. Tonix does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in the Annual
Report on Form 10-K for the year ended December 31, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, and periodic reports filed with the SEC on or after the
date thereof. All of Tonix's forward-looking statements are
expressly qualified by all such risk factors and other cautionary
statements. The information set forth herein speaks only as of the
date thereof.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
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